Kornimate/medical-research-clean huggingface dataset:
anastomotic leakage after anterior resection for rectal cancer - predictive biomarkers and rectal blood flow

Conditions: Anastomotic Leak

Summary: the purpose of this study is to determine whether reduced rectal blood flow is associated with the extent of surgery when performing an operation to remove rectal cancer. the investigators also aim to describe any relation of reduced rectal blood flow, as well as raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage. the patients will be recruited at umeå university hospital and all patients who are planned to undergo anterior resection for rectal cancer and able to consent are eligible for this study. rectal blood flow measurements will be conducted with laser-doppler technology using noninvasive measuring probes. preoperative and postoperative blood sampling as well as postoperative drain fluid collection will take place. perianastomotic tissue will also be collected. in the postoperative period, any occurrence of surgical complications especially anastomotic leakage, will be noted. blood flow and biomarkers will be assessed in relation to type of mesorectal excision (total or partial) and correlated to anastomotic leakage. standard statistical tools will be utilized, such as parametric, non-parametric tests and logistic regression, as appropriate. the study will recruit approximately 40 patients during three consecutive years.


Eligibility criteria:
inclusion criteria: * planned anterior resection for rectal cancer * willing to participate exclusion criteria: * not willing to participate * unable to consent

Keywords: rectal neoplasms
comparison of three tourniquet application methods in primary total knee arthroplasty surgery

Conditions: Knee Osteoarthritis

Summary: different strategies of tourniquet application during elective primary total knee arthroplasty are thought to be associated with different outcomes. in that context, the study investigates different tactics in the search of optimal application of the tourniquet and the related fluid management during 24 perioperative hours.

the optimal application of tourniquet should reduce perioperative blood loss, create bloodless operative field, improve cementing technique and shorten surgery time. meanwhile, inadequate application may increase the risk of deep vein thrombosis and pulmonary thromboembolism. previous attempts to compare the tourniquet strategies in respect to the perioperative blood loss did not show significant difference. the investigators use the volume loading test aiming to optimize the fluid status and obtain the hemoglobin concentration in the conditions of standardized plasma dilution. the test is deployed just before the surgery and after postoperative 24 hrs in icu. functional outcomes and possible length of hospital stay is also evaluated.

Eligibility criteria:
inclusion criteria: * patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia * age \> 50 and \< 80 years * asa (american society of anesthesiology classification) ii physical status * signed informed consent form exclusion criteria: * history of a bleeding disorder * current chronic anticoagulation therapy * history of dvt (deep vein thrombosis), thromboembolic complications, acute cardiac insufficiency * anemia before surgery required blood transfusion * asa i, asa\>=iii physical status * age \ 80 years * bmi (body mass index) \ 40kg/m2 * intravascular fluid infusion within 24 hours before study * chronic non-steroidal anti-inflammatory drug use (more than 6month daily use) * rheumatoid arthritis * diabetes mellitus * psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors) * alcohol intake 5 u daily * contraindication to epidural catheter insertion * surgery not by project surgeon * participation in the other study * active malignancy * previous open knee surgery

Keywords: total knee arthroplasty tourniquet blood loss volume loading test
an interactive empowerment tool for breast cancer patients

Conditions: Breast Cancer; Empowerment

Summary: the study is aimed to verify the effect of an online interactive tool on patient empowerment. the tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.

the study is intended to develop an iem (interactive empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. developed in the framework of the fp7 project "p-medicine", the iem tool uses the alga-bc questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. as soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.

Eligibility criteria:
inclusion criteria: 1. the patient is aged 18 to 74 years at randomisation. 2. the patient has been diagnosed as having a primary breast cancer requiring a radical surgery 3. the patient is able to understand the informed consent form, and understand study procedures. 4. the patient has signed the informed consent form. exclusion criteria: 1. the patient has a recurrent breast cancer diagnosis 2. the patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire 3. inability to freely consent to take part in the study 4. inability to understand the study materials. 5. current participation in another clinical trial relating to the breast cancer treatment 6. any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.

Keywords: empowerment communication shared decision making
left atrium reservoir function modulation in patients with atrial fibrillation: digoxin versus beta blocker

Conditions: Atrial Fibrillation; Left Atrial Rhythm

Summary: ß blocker and digoxin effect on left atrium reservoir function are unknown. this is a randomized open label study to compare the effect of theses two molecules on left atrium function

atrial fibrillation (af) is responsible of significant morbidity and mortality. management of signs and symptoms of heart failure generated by af is at the center of the latest european recommendations . mechanisms by which these symptoms are generated are very poorly understood. heart rate control is one of the recommended strategies but remains poorly codified and generally follows the preferences and experiences of each local center. the european guidelines propose at least 4 molecules for heart rate control without emitting preferences for one molecule over the other due to the lack of robust randomized studies. recently, a study comparing digoxin vs ß-blockers showed the superiority of digoxin in decreasing symptoms despite a comparable action on heart rate. on the other hand, the reservoir function of the left atrium (la) has taken a central role in assessing signs of left heart failure and monitoring filling pressures . other studies have demonstrated the association of left atrium reservoir strain with these symptoms . it is commonly accepted that ß blockers decrease af-related symptoms by a negative chronotropic effect thanks to their blocking action on the sympathetic system. while the action of digoxin on symptoms goes through a positive inotropic effect thanks to the increase in intracellular calcium . however, the impact of these two molecules on the function of the left atrium has never been investigated. our diagnostic hypothesis is that in addition to their action on heart rate, the improvement of symptoms noted by using b blockers and digoxin during the treatment of af would go through an improvement la reservoir function . the superiority of digoxin in the reduction of symptoms compared to ß blockers would be due to a greater improvement in reservoir function and this thanks to the increase in myocardial intracellular calcium.

Eligibility criteria:
inclusion criteria: * any patient with atrial fibrillation naïve to ß-blocker and digoxin or patients followed for atrial fibrillation and discontinued all treatment for more than a week. * frequency control strategy decided * age over 18 years * stable hemodynamic state * no contraindication to digoxin or ß-blocker exclusion criteria: * required rhythm control strategy * contraindication to one of the two * heart rate \<60 bpm * clearance rénale \<30 ml/mn * pregnant or breastfeeding woman * persistence of a resting heart rate \> 110 * severe comorbidity with decreased life expectancy (advanced neoplasia, large stroke...)
the use of bioimpedance to determine pre-clinical lymphedema in the post-operative breast cancer patient

Conditions: Breast Cancer

Summary: primary objective: to determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. secondary objectives:to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema. tertiary objective: to determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema. the successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. in addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. and most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. bryn mawr hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery. study design:randomized, pilot study

primary objective: to determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. secondary objectives:to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema. tertiary objective: to determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.

Eligibility criteria:
inclusion criteria: * are female * have operable, early stage breast cancer stage 0 - iiia * undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection * are aged \> 18 years of age at the date of enrollment * are willing to sign an informed consent form exclusion criteria: * are male * have had a bilateral axillary surgery * do not undergo axillary evaluation * are a minor * cannot consider the issues involved in making an informed and autonomous decision.

Keywords: breast cancer lymphedema sentinel node biopsy axillary dissection
nelfinavir, a phase i/phase ii rectal cancer study

Conditions: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal

Summary: the aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied

objective of the study: the aim is to study safety and activity of nelfinavir, added to standard chemoradiotherapy (28x1.8 gy and capecitabine 825 mg/m2 bid) in patients with locally advanced rectal cancer. furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumor tissue will be studied. study design: this is an open label, single-center phase i/ii trial. during phase i the toxicity of 2 dose levels will be studied (750 mg bid and 1250 mg bid). during phase ii the activity of nelfinavir in combination with capecitabine and radiotherapy will be studied, using the mtd from phase i. with respect to translational research, phosphorylation of akt in monocytes and tumorcells will be measured at different timepoints during treatment. furthermore, dynamic ct-pet scans will be obtained at different time points to get an impression of changes in suv and perfusion during treatment and to correlate these changes with pathological response. study population: patients with locally advanced rectal cancer, who are candidates for chemoradiotherapy. in phase i, 6 patients will be included. in case of the occurrence of dose limiting toxicity, extra patients will be included, according to the rules described in the protocol. in phase ii, 55 patients will be included.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the rectum (tumor \<15cm from anal verge) * age \>= 18 years * uicc t3-4 n0-2 m0 * who performance status 0-2 * less than 10 % weight loss the last 6 months * no recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction) * serum bilirubin = or \< 3x normal * asat and alat = or \< 2,5x normal * creatinin clearance \>50 ml/min * willing and able to comply with the study prescriptions * no history of prior pelvic radiotherapy * no known hiv infection * no hemophilia * no concurrent medication that is metabolized by the cyp3a4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam) * statins should be stopped (except pravastatin and fluvastatin), * no concurrent use of st. john's wort (hypericum perforatum) * women should not be pregnant or lactating * being willing and able to undergo one extra biopsy * have given written informed consent before patient registration exclusion criteria: * the opposite of the above

Keywords: locally advanced rectal cancer nelfinavir radiosensitivity chemoradiation
vaccination of ajcc stage iib, iic, iii and iv melanoma patients with human and mouse tyrosinase dna vaccines

Conditions: Melanoma; Skin

Summary: the overall goal of this study is to find out about the safety of injecting the genes (dna) for human and mouse tyrosinase in patients with melanoma. there is no evidence yet that injection of tyrosinase dna results in any clinical benefit. tyrosinase is the substance found in melanoma cells that helps to produce their black color. the dna used in this study was purified from bacteria which contains the gene for tyrosinase. dna is material which contains the information needed to produce many substances in the body.


Eligibility criteria:
inclusion criteria: * patients must have documented malignant melanoma, american joint commission on cancer (ajcc) stage iib, iic, iii or iv. patients free of disease after surgical resection will also be eligible. * for all patients, pathology slides must be reviewed by the memorial hospital department of pathology for confirmation of melanoma diagnosis. * patients must be hla-a0201 positive. * patients must be at least 18 years of age to be eligible and must be able to read the informed consent and give informed consent. * patients must have a karnofsky performance status of at least 80. * ldh \ than or = to 3.5 mg/dl. * a cbc prior to vaccination with wbc \> or = to 3000, platelets \> or = to 100,000. * patients must be free of detectable brain metastases. exclusion criteria: * patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks. patients must be fully recovered from any previous therapy or surgery. * patients may not have been previously immunized with vaccines containing tyrosinase or peptides derived from tyrosinase. * any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the principal investigator or co-principal investigators. * patients who have preexisting retinal or choroidal eye disease will be excluded. * patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible. * pregnant women or women who are less than 3 months post-partum are not eligible. women who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. women of child-bearing potential must not be pregnant (negative bhcg within 2 weeks of vaccination) nor be nursing during treatment.

Keywords: dna hu & mouse tyrosinase
resveratrol trial for relief of pain in pseudoachondroplasia

Conditions: Pseudoachondroplasia

Summary: the purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo. another goal of this study is to evaluate side effects in this population.


Eligibility criteria:
inclusion criteria: * the diagnosis of pseudoachondroplasia is based on clinical assessment either in person or by photographic review by skeletal dysplasia specialist (jth), * healthy beyond pseudoachondroplasia associated complications, exclusion criteria: * current use of resveratrol * current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine and triazolam. * other non-pseudoachondroplasia related health conditions, e.g. cancers. * pregnancy or breastfeeding. women must use adequate contraception during the study. * participation in another clinical study and/or using investigational agents. * use of non-steroid anti-inflammatory (nsaids) or aspirin. * current use of alfentanil, cyclosporine, dihydroergotamine, dofetilide, ergotamine, fentanyl, flibanserin, oxycodone, pimavanserin, pimozide, quinidine, saquinavir, sirolimus, tacrolimus, temsirolimus, theophylline, tizanidine, thioridazine, fosphenytoin, phenytoin or warfarin. * baseline level of pain of 2 or higher on 10 point scale. * platelet count below 50,000 per ul on baseline complete blood count (cbc).

Keywords: resveratrol joint pain
evaluation of an adapted formula on atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: the aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.

the study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. during this period of time, all infant include in the study will be fed with the study formula.

Eligibility criteria:
inclusion criteria: * aged below 18 month * having an atopic dermatitis diagnosed according to the united kingdom working party - having an eczema area severity index (easi) between 7.1 and 50.0 * whose parents gave their informed consent exclusion criteria: * systemic corticotherapy * antihistamine * use of dermocorticoide and/or antibiotics within 15 days * symptoms of cutaneous infection * past anaphylactic shock * cow's milk, soya or fish allergy * exclusive or predominant breast feediing (more than one feeding/day) * consumption of less than 500 ml per day * participation to another trial.
improving bone health in adolescent girls: the youth osteoporosis and understanding total health (youth) study

Conditions: Osteoporosis

Summary: osteoporosis affects nearly half of all american women over age 50. during the teenage years, girls can increase bone growth to decrease their risk of osteoporosis later in life. this study will test whether girls can change their food intake and physical activity patterns in ways that will increase their bone growth during the mid-teen years.

osteoporosis-related fractures incur an annual cost in the united states of more than $8 billion. peak bone mass is achieved in the late teens and early 20s. an important component of a lifelong osteoporosis prevention strategy is to maximize bone mineral content during the teen years and establish lifestyle patterns that will help maintain bone mineral content through menopause. this trial will test the efficacy of a comprehensive lifestyle intervention to build bone and prevent bone loss among adolescent women 14 to 16 years of age. participants in this study will be randomized to either an intervention group or an attention control group. the intervention program includes a physical activity component involving high impact and spinal motion activities and a diet component rich in fruits, vegetables, and calcium. participants will take part in group and individual meetings and activities and receive coaching telephone calls. participants will be assessed at study entry and two annual follow-up visits. primary outcome measures include objective measures (serum folate and carotenoids urinary sodium, lean body mass, accelerometer measure of physical activity) and self-reports.

Eligibility criteria:
inclusion criteria * high school freshman or sophomore * body mass index (bmi) from 16 through 23 * member of kaiser permanente northwest health plan * parent or guardian willing to participate exclusion criteria * co-morbidity requiring a specific diet * medication which contraindicates consuming a high-fiber diet * life-threatening disease or other condition that would interfere with study participation * current or past medically or self-diagnosed eating disorder * current behaviors consistent with eating-related disorder * pregnancy * diagnosis of psychological disorder or difficulty within the past year